C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1718500 |
Device Problems
Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524); Material Split, Cut or Torn (4008)
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Patient Problems
Unspecified Infection (1930); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2021).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
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Event Description
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It was reported that sometime post a port placement in the left side of chest, the patient allegedly experienced a port pocket infection.It was further reported that the port allegedly leaked and the pustulous liquid oozed from the port access site.Furthermore, it was also reported that sometime ago, the patient allegedly had fibrin buildup issue and was given clot busters to treat fibrin issue.Reportedly, patient was provided antibiotics to treat port infection and has cleared up.The current status of the patient is unknown.
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Event Description
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It was reported that sometime post a port placement in the left side of chest, the patient allegedly experienced a port pocket infection, bruising, and swelling around the port site.It was further reported that the port allegedly leaked and the pustulous liquid oozed from the port access site.Furthermore, it was also reported that sometime ago, the patient allegedly had fibrin buildup issue and was given clot busters to treat fibrin issue.Reportedly, patient was provided with antibiotics to treat port infection and has cleared up.The port was removed.The current status of the patient is unknown.
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.Multiple splits were noted throughout the port septum.Hydrostatic pressure was applied by clamping the distal end of the catheter while infusing to observe for leaks; leaks from the port septum were observed.Therefore the investigation is confirmed for the reported leak and identified material split, cut /torn issues.However the investigation is inconclusive for the reported fibrin buildup issue as the reported event cannot be confirmed from the returned sample.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiration date: 08/2021) (method, result, conclusion) section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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